Welcome to the CAPRA Blog
Post-NOC Level III Change Updates
Author: Karen Zhou A post-NOC change is any change made to a new drug that has received a notice of compliance (NOC) pursuant to C.08.004 of the Food and Drug Regulations. In...
Cybersecurity – Draft Guidance Document
Author: Karen Zhou Medical devices play a pivotal and ever increasing role in improving access to care for patients. Through data exchange with network environments, medical...
Proposed Amendments to Regulations under the Ontario Drug Benefit Act and the Drug Interchangeability and Dispensing Fee Act
Author: Bhavesh Patel, C. Chem. Natco Pharma (Canada) Inc. The Ministry of Health & Long-Term Care recently announced proposed amendments to the regulatory scheme affecting...
Software as Medical Devices (SaMD) – Where to go from here?
Author: Karen Zhou In an era of mobile apps on smartphones and tablets, Canada’s current software regulatory framework is long overdue for revision. Because the healthcare...
Device Advice: Health Canada Launching a New Pilot Project to Formalize Regulatory Advice Framework for Medical Device Manufacturers
Author: Bhavesh Patel, C. Chem. Health Canada recently announced it is the process of formalizing a meeting framework called "Device Advice: Pre-Clinical Meetings", where...
Health Canada Update on Investigational Testing Authorizations for Medical Devices
Author: Pinky Mazumder Investigational Testing Authorization (ITA) issued by Health Canada, allows for the testing of Class II, III, and IV medical devices with human...
Toward Global Harmonization - Health Canada to Adopt IMDRF Table of Contents Format for Class III and IV Applications
Author: Karen Zhou In another move toward global harmonization, by April 1, 2019, medical device manufacturers will be required to submit premarket applications for Class III...
The Long-Awaited Legalization of Cannabis in Canada
Author: Pinky Mazumder On October 17th, 2018, the long-awaited legalization of cannabis will come into effect. Cannabis will no longer be subject to the Controlled Drugs and...
Upcoming Guidance Development on the Licensing Requirements for 3D-Printed Devices
Author: Bhavesh Patel, C. Chem. Natco Pharma (Canada) Inc. Health Canada recently announced the development of a draft guidance document to assist medical device...
Certificate of Supplementary Protection (CSP) – Updated Guidance
Author: Karen Zhou Health Canada recently announced an update to Guidance Document: Certificate of Supplementary Protection Regulations . The purpose of the guidance is to...
Health Canada: Plan to Phase out Most Uses of Clothianidin and Thiamethoxam
Author: Bhavesh Patel Neonicotinoids are a class of pesticides used to control insects on a variety of agricultural crops, including seed treatments, and on turf and...
Vanessa’s Law – Taking a First Look
Author: Karen Zhou Vanessa’s Law (Protecting Canadians from Unsafe Drugs Act ), first enacted in 2014, added section 21.1(3) to Canada’s Food and Drugs Act to permit the...
Guidance on Notifying Health Canada of Foreign Actions
Author: Pinky Mazumder The guidance document on Notifying Health Canada of Foreign Actions (the “Guidance Document”) is intended to help Market Authorization Holders (“MAH”)...
Strengthening Post-market Surveillance and Risk Management of Medical Devices in Canada
Author: Bhavesh Patel, C. Chem. Health Canada recently informed stakeholders, in particular manufacturers and importers of medical devices, of its intent to propose...
Health Canada: Transition to Global Medical Device Nomenclature
Author: Karen Zhou Health Canada has announced that it is initiating the transition to the Global Medical Device Nomenclature (GMDN) as a medical device categorization...
Antimicrobial Resistance and Health Canada’s Pathogens of Interest List
Author: Pinky Mazumder Antimicrobial resistance is currently recognized as a worldwide public health concern due to difficulty in treatment. In response, Health Canada is...
ICH E18: Genomic Sampling and Management of Genomic Data
Author: Bhavesh Patel, C. Chem. Health Canada recently announced the implementation of ICH guidance E18: Genomic Sampling and Management of Genomic Data (the “Guidance”). The...
Consultation on Prescription Drug Transparency
Author: Pinky Mazumder From September 28th to October 28th 2017, the Therapeutic Products Directorate (TPD) of Health Canada held an online consultation on five proposed...
Final Notice: Classification of Dental Plaque-Disclosing Products as Drugs
Author: Bhavesh Patel, C. Chem. Last month, Health Canada posted a notice for consultation with industry and other stakeholders of its intention to regulate dental...
Australia Canada Singapore Switzerland (ACSS) Consortium - New Chemical Entities Work Sharing Trial Phase I
Author: Karen Zhou The Australia Canada Singapore Switzerland (ACSS) Consortium was established to foster collaboration and synergy between regulatory authorities to address...
Health Canada Notice on eCTD submission of Master Files
Author: Pinky Mazumder On May 7, 2018 Health Canada published a notice announcing the start of a 90-day consultation on the submission of Master Files in eCTD format....
Medical Device Single Audit Program Reduction of Audit Times for small-sized enterprises – update
Author: Bhavesh Patel, C. Chem. Health Canada is continuing to work towards the target date of January 1, 2019 to transition to MDSAP Quality Management System certificates...
Health Canada implements ICH guidance E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population
Author: Karen Zhou Health Canada has announced the implementation of the ICH guidance E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric...
Health Canada Adapts to Digital Health Technologies
Author: Pinky Mazumder Digital health technologies are a rapidly growing area in the area of healthcare. These technologies encompass a wide range of products, from single...
Release of Proposed IMDRF Document: Definitions for Personalized Medical Devices
Author: Bhavesh Patel, C. Chem. The International Medical Device Regulators Forum (IMDRF) recently published a Proposed Guidance Document titled Definitions for Personalized...
Health Canada Continues to Tweak Requirements for MDSAP Transition
Author: Karen Zhou Manufacturers who sell medical devices in the Canadian market are required to submit MDSAP certificates by December 31, 2018. The Medical Device Single...
Health Canada Notice on ICH Selection and Justification of Starting Materials for the Manufacture of Drug Substances
Author: Pinky Mazumder On April 4th, 2018 Health Canada issued a Notice to announce its implementation of the ICH Q11 final guidance document on Questions and Answers:...
Health Canada: Guideline for Residual Solvents
Author: Bhavesh Patel, C. Chem. Health Canada recently announced the implementation of the ICH Guidance “Q3C(R6) Impurities: Guideline for Residual Solvents” (the “Guidance”)...
The Australia Canada Singapore Switzerland (ACSS) Consortium
Author: Pinky Mazumder With the evolving nature of medicines and treatments, regulatory agencies across the world are encountering similar challenges during the review and...
Administrative Processing of Submissions and Applications: Human or Disinfectant Drugs
Author: Bhavesh Patel, C. Chem. On March 1, 2018, the guidance document “Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs” (the...